Pentax Medical Video Duodenoscope Recalled for Distal End Cap Detachment Risk
Pentax of America Inc. is recalling 108 Pentax Medical Video Duodenoscopes because the distal end cap may detach during procedures, posing risks of injury or aspiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of physical injury (mucosal injury, lacerations, bleeding, aspiration) from a medical device component detaching, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pentax of America Inc. is recalling 108 units of the Pentax Medical Video Duodenoscope, Model ED34-i10T2. The recall is due to a risk that the OE-A63 distal end cap may unexpectedly become detached during a procedure. This detachment can result in unforeseen events such as mucosal injury, lacerations, or bleeding of the patient. Additionally, if the detached cap enters the patient's oral cavity, it may result in aspiration.
The affected devices were distributed nationwide in the United States, specifically in Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, and Washington, D.C. The recall covers all units of the specified model.
Pentax of America Inc. has updated the Instructions for Use (IFU) for both the OE-A63 distal end cap and the ED34-i10T2 duodenoscope. These updates notify users of the associated risks with the distal end cap detaching and provide instructions on immediate actions to take if this event occurs. Users should review the updated IFU for safety guidance.
The recalled product
- Product
- Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED3
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units
Distribution
Related recalls
Same manufacturer · Pentax of America Inc
See all →- HighEndoscopy video processors recalled over hot light guide and thermal injury risk
FDA (Devices) · 2025-08-27
- HighVideo Colonoscope May Cause Thermal Burns to Tissue During Use
FDA (Devices) · 2025-03-05
- HighPENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall
FDA (Devices) · 2025-03-05
- HighPentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk
FDA (Devices) · 2025-03-05
- HighPentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions
FDA (Devices) · 2021-09-22
Same hazard · injury
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereQuantum Rehab Q6 Edge 4 Wheelchairs Recalled Due to Controller Software Issue
FDA (Devices) · 2026-08-12
- SevereNissan Recalls 2025 Altima Vehicles Due to Air Bag Fastener Defect
NHTSA · 2026-08-12
- HighChrysler Recalls Mopar Seat Belt Assemblies Due to Retraction Failure
NHTSA · 2026-08-06